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Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to monacolin K from red yeast rice and maintenance of normal blood LDL cholesterol concentrations. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders.

The food that is the subject of the health claim is red yeast rice (i.e. rice fermented with the red yeast Monascus purpureus). The Panel considers that, whereas red yeast rice is not sufficiently characterised in relation to the claimed effect, the food constituent, monacolin K from red yeast rice, is sufficiently characterised.

The claimed effects are “cholesterol” and “cholesterol management/heart health”. The target population is assumed to be adults in the general population. In the context of the proposed wordings, the Panel assumes that the claimed effect refers to maintenance of normal blood LDL cholesterol concentrations. The Panel considers that maintenance of normal blood LDL cholesterol concentrations is a beneficial physiological effect.

In weighing the evidence, the Panel took into account that two randomised controlled trials provided from which conclusions could be drawn for the scientific substantiation of the claim showed an effect of red yeast rice preparations providing a daily dose of about 10 mg monacolin K on LDL cholesterol concentrations in individuals with hypercholesterolaemia, that the effect of pure monacolin K on LDL cholesterol concentrations is well established and that the mechanism by which monacolin K can contribute to the claimed effect is well known.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has been established between the consumption of monacolin K from red yeast rice and maintenance of normal blood LDL cholesterol concentrations.

The Panel considers that in order to obtain the claimed effect, 10 mg of monacolin K from fermented red yeast rice preparations should be consumed daily. The target population is adults in the general population.

In relation to restrictions of use, the Panel refers to the Summary of Product Characteristics of lovastatin containing medicinal products available on the EU market.